RecruitingNot ApplicableNCT06513156

Continuum of Care in Hospitalized Patients With Opioid/Stimulant Use Disorder and Infectious Complications From Drug Use

Continuum of Care in Hospitalized Patients With Opioid or Stimulant Use Disorder and Infectious Complications of Drug Use - Substance Use/ID Integrated Clinic vs. TAU to Prevent Infection Related Readmission

Sponsor

Elana Rosenthal

Enrollment

304 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Opioid-use Disorder Stimulant Use Disorder Injection Related Infections

Summary

This is a two-group randomized controlled trial conducted at five hospitals across the U.S. designed to test the effectiveness of an Integrated infectious diseases/Substance Use Disorder outpatient clinic (IC) compared to treatment as usual aimed at reducing infection related readmissions and improving health outcomes in people hospitalized with an infection related to injecting opioids or stimulants.

Eligibility

Min Age: 18 Years

Inclusion Criteria27

Age ≥ 18 years
Admitted to study hospital (defined as hospitalized with a primary team that is not Emergency Medicine)
Injection opioid or stimulant use in past 90 days - per patient self-report
Active suspected or confirmed qualifying infection (see list) at time of admission.
Qualifying infections:
Non-vertebral osteomyelitis
Vertebral osteomyelitis or discitis
Epidural, subdural, or extradural abscess
Intracranial or intraspinal abscess
Native joint septic arthritis
Prosthetic joint septic arthritis
Blood stream infection (bacterial or fungal)
Native valve Endocarditis
Prosthetic valve endocarditis
Cardiac Implantable electronic device infection
Infectious pseudoaneurysm and aneurysm
Infected vascular graft
Septic venous thrombosis
Skin and Soft tissue infection (cellulitis, skin abscess, necrotizing fasciitis)
Infected skin ulcer
Orthopedic hardware infection
Muscle abscess/myositis
Central nervous system infection (bacterial or fungal)
Bacterial or fungal ophthalmologic infection
Other abscess
Pulmonary septic emboli
Other acute bacterial or fungal infection deemed appropriate by site study team

Exclusion Criteria3

\. Infection due to a cause other than injection drug use, per determination of a site PI.
\. Inability to provide consent due to circumstance (e.g., sedated, intubated), language, or cognitive impairment.
\. Unwilling to provide informed consent 4. Unable to receive potential interventions due to geography 5. On comfort measures or planned for discharge to hospice care 6. Incarcerated at the time of hospitalization 7. Other criteria at the discretion of the site investigator

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Interventions

BEHAVIORALIntegrated Infectious Diseases and Substance Use Disorder Clinic (IC)

Integrated medication for opioid/stimulant use disorder and infectious disease care provided into single appointment either in person or via telemedicine with a minimum of monthly appointments for 6 months.